Implanted defibrillators linked to patient deaths and injuries.

Implantable defibrillators are embedded in tens of thousands of people's chests. They are intended to save lives by shocking an abnormally beating heart back to a normal rhythm, but some have defects that cause them to malfunction, injuring and killing patients, recent lawsuits say. On July 1, the FDA recalled 11 types of defibrillators made by Guidant Corp., based in Indianapolis.

Guidant first alerted doctors about a possible defect the night before a May 24 New York Times article reported the March death of 21-year-old Joshua Oukrop, whose defibrillator short-circuited. Although Guidant knew of other instances of the defect and had fixed the problem in its manufacturing process three years earlier, it had not told doctors about it. (Barry Meier, Maker of Heart Device Kept Flaw from Doctors, N.Y. TIMES, May 24, 2005.)

"Then the company backpedaled overnight," said Paul Pennock, a New York City lawyer who filed a class action representing patients with Guidant heart devices that may need to be removed, as well as estates of people who died because of the defect. An amended complaint was filed in July, and claimants are estimated in the tens of thousands. At press time, the action was awaiting assignment to multidistrict litigation (MDL). (Wenig v. Guidant Corp., No. CV-05-2822 (E.D.N.Y. amended complaint filed July 25, 2005).) Dozens of lawsuits have been filed against Guidant since May.

The recalls do not necessarily mean the devices should be replaced, but they leave doctors and patients with the difficult task of weighing the risks of surgery to replace the defibrillator against the risk that it will fail to work when needed. Doctors cannot tell whether a particular device is defective until after it has malfunctioned.

Tobias Millrood, a Radnor, Pennsylvania, lawyer, said Guidant was aware of specific instances when the defibrillators failed after abnormal heart rhythms were induced intentionally. According to the New York Times article, in three instances when doctors induced abnormal heart rhythms during routine patient checkups, the devices failed to work, and the doctors had to use external defibrillators to save the patients.

"Instead of disclosing this defect to doctors and patients, or recalling the device altogether, Guidant put profits over safety and continued to allow the flawed devices to be surgically implanted in patients," said Millrood, who filed a class action in federal court in Pennsylvania in July. (Perusich v. Guidant Corp., No. 05-CV-3580 (E.D. Pa. filed July 12, 2005).)

Guidant has declined to comment in the media on the pending lawsuits, but in a July 1 statement, Guidant President and CEO Ronald Dollens said, "The health and safety of patients is paramount.... Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients."

Because the devices may short-circuit while attempting to shock the heart, the FDA classified the recalls of Guidant's Prizm 2 DR, Contak Renewal, and Contak Renewal 2 defibrillators as Class I--which means "there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death." According to a July I FDA statement, two deaths had been associated with the defect, out of 42,000 devices worldwide. (At the time, about 20,600 still were implanted.)

The FDA issued Class II recalls of the Ventak Prizm AVT, Vitality AVT, and Renewal AVT defibrillators due to a memory error. Class II means a defective device "may cause temporary or medically reversible adverse health consequences," but "the probability of serious adverse health consequences is remote." The FDA statement said two incidents of the error were confirmed out of 21,000 devices implanted worldwide, although they did not result in death or injury.

Guidant originally advised doctors to reprogram these models. But on July 11, a third memory error occurred in a defibrillator that had been reprogrammed. The company reversed its recommendation in a July 22 letter to doctors saying that reprogramming actually can increase the risk of the problem.

In an August 8 letter to patients, Guidant confirmed that three more devices had failed and said it was continuing to investigate additional events. "We deeply regret any inconvenience or apprehension this may have caused you or your loved ones," the letter says.

"The patients who have these devices are really test subjects, because the manufacturer is still identifying new defects and proposing new solutions," said Robert Spohrer, a Jacksonville, Florida, lawyer. "People are at a loss as to what to do."

The FDA also issued Class II recalls of Guidant's Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF. A magnetic switch on these models may become stuck, preventing the device from working and accelerating battery depletion. The FDA statement says four occurrences were confirmed out of 46,000 such devices. On August 1, Guidant announced it had received FDA approval to resume selling the Contak Renewal 3.

Larry Hardin, a 58-year-old Texas man, is suing Guidant for selling him a defibrillator it knew was subject to a short-circuit defect. His lawsuit includes allegations of fraud, negligence, battery, and intentional infliction of emotional distress. Hardin's defibrillator, like Oukrop's, was a Prizm 2.

"Guidant affirmatively misrepresented the problem for three years to the FDA and doctors," said Robert Hilliard, a Corpus Christi, Texas, lawyer representing Hardin. His defibrillator was implanted after the improved version was already on shelves, Hilliard said. Hardin's lawsuit requests that Guidant pay for monitoring to determine whether his defibrillator is still working and for removing the device, if necessary. The case was filed in state court in June and then removed to federal court. (Hardin v. Guidant Corp., No. 3:05-CV-430 (S.D. Tex. Aug. 5, 2005).)

As soon as Guidant found out about the problem, it "should have dumped the old units and told the FDA at that point," said Hilliard, who is working on about 50 other cases against the manufacturer. Among those suing is 62-year-old Louis Motal, whose defibrillator shocked him five times on one occasion when it malfunctioned.

"We shouldn't have to rely on investigative reporting" to uncover patient risks, Hilliard said. He added that Guidant was obligated to disclose any design flaws it was aware of, even those less serious than the short-circuit defect.

Spohrer represents Robert Earl Smith, whose father, Bobby Smith, died when his Prizm 2 defibrillator failed. Smith filed a class action against Guidant for wrongful death, alleging negligence and products liability. "The family received the recall notice after Mr. Smith had died," Spohrer noted. At press time, the class had not yet been certified, the case had been removed to federal court, and Guidant was seekingMDLstatus. (Smith v. Guidant Corp., No. 305-CV-728-J-20 (M.D. Fla. Aug. 2, 2005).)

Some class members are spouses or children of people who died when the devices failed to work; others acquired infections as a result of having the defibrillator replaced or were shocked by the device when shocks were not needed. When one man was shocked unnecessarily, he fell and fractured his jaw and nose, Spohrer said. Other class members have no symptoms but may have to undergo an otherwise unnecessary surgery to replace the defective device.

Another manufacturer, Medtronic, Inc., also faces lawsuits after recalling some of its implantable defibrillators in April for a defect in which the device may take too long to charge before shocking the heart, delaying the needed shock therapy. Medtronic said one injury and four deaths may be related to the defect.

Disclosure delayed

Guidant should have alerted the FDA, patients, and doctors about the defects immediately, said Pennock, the New York attorney.

"It's outrageous to think that anyone would choose the old, defective device," said Teresa Toriseva, cochair of ATLA's Heart Devices Litigation Group. If these cases establish in court that Guidant continued to knowingly sell the defective Prizm 2, "that's the type of intentional misconduct that's the perfect punitive damages situation and exactly why punitive damages were created," she said.

Guidant could have notified doctors and patients in away that didn't alarm or scare them, Toriseva said. In deciding not to disclose the risk, the company "usurped, first of all, the medical judgment of the physicians in determining what was best for the patients, and second, the informed-consent right that patients have," she noted.

So where should the line be drawn between needlessly alarming people and warning them of potentially dangerous problems? "You err on the side of safety," Spohrer said.

Some doctors have said they wish they had known about the defects earlier so they could have replaced the devices for high-risk patients. Anne Curtis, president of the Heart Rhythm Society, an organization of cardiac physicians and associated professionals, noted that the defects have created problems for doctors. "We're obligated to call all these patients in for a discussion about whether to change out the devices, which creates a big burden for physicians and their staff to deal with," she said.

Defibrillators are not Guidant's only problem. On July 22, the FDA announced the Class I recall of nine types of Guidant pacemakers that may fail due to a sealing component that could degrade and allow too much moisture into the pacemaker case.

In 2003, a Guidant subsidiary pleaded guilty to misleading the FDA about a malfunctioning stent-graft device. Toriseva said of the plea agreement: "'We'll change our ways' was the essence of it, and it doesn't seem that the ways have changed at all. And I don't think it bodes well for the corporate culture."

Hilliard agreed. "This is a perfect example of how skeletons don't stay in the closet," he said.

Pennock noted that there appeared to be conflicts among Guidant employees about whether the company hid information after the defibrillator problem was identified. "What we'll probably find is that there was a lot of information being buried in the device retrieval department," he said.

"I think if the public had a sense that companies were being open, there would actually be less alarm and more calm in the sense that people think, 'We have all the information, we can make intelligent choices,'" Toriseva said. But as it is, "people don't know if they can trust what's being told to them by the company, and that's actually a worse problem."

Meanwhile, securities fraud lawsuits filed against Guidant allege that company executives sold stock at inflated prices when they knew about the defibrillators' undisclosed flaws.

FDA involvement

Some critics have faulted the FDA for inadequately monitoring drugs and medical devices after they reach the market. But could the agency have done anything to prevent the Guidant problem?

The FDA doesn't deserve the blame, Spohrer said. "The FDA is a small agency of the federal government. It is not well funded and does not have nearly the manpower nor the expertise to test and determine the safety and efficacy of all of the products that come under its jurisdiction."

The FDA probably didn't know the devices were defective, Hilliard said, but it did not adequately police Guidant. "The FDA is supposed to be a watchdog, but it is a political group, and it is a complacent environment."

In July, Sen. Charles Grassley (R-Iowa), chairman of the Senate Committee on Finance, requested information from the FDA about why defibrillator and pacemaker performance data reported to the agency was not publicly available. The New York Times asked for Guidant's annual reports from the FDA via a Freedom of Information Act request, but the agency said in early August that it would not release the data because it was considered a corporate trade secret.

"Until the New York Times article came out, no one knew to ask for those FDA records [on defibrillator malfunctions]," Toriseva said. "There needs to be some mechanism in place that forces the disclosure."

She added, "I think the problems at the FDA run deep, but that doesn't excuse the company's own misconduct."

Tough choices

Patients' decisions about whether to replace the devices vary, Toriseva said. "Some people can't have them explanted for various reasons, some are choosing not to, and some have no choice or are choosing to replace them because of the overwhelming fear and anxiety of having the defective device--and that in and of itself can be a health risk."

The Heart Rhythm Society held a conference in September to discuss the pacemaker and defibrillator recall processes and develop a more explicit set of guidelines for doctors to follow when they are faced with a safety alert or recall. "Simply notifying physicians is not the answer. Then what do they do? There has to be notification with some thoughtful analysis," Curtis said.

The cost of replacement surgery, and how much Guidant might cover, clearly is a concern to patients. But it also "is a huge expense to hospitals--for the indigent--and to health insurance companies," Spohrer noted.

Hilliard added that another problem is emerging for patients: Some are finding Guidant representatives present at every appointment they have with their doctors. "One of my clients said she can't talk to her doctor privately without a Guidant rep being in the room," he said.

"This is just the latest example of how the civil justice system operates to enforce safety in the marketplace," Spohrer said. "People think it's the job of the FDA or Congress, but they can't be expected to police everything, and we know the manufacturers can't be counted on to reliably enforce the rules themselves. So it falls to the trial bar and the civil justice system to make sure there is accountability."